ANTACID SUPREME CHERRY- mylanta supreme cherry suspension 
P & L Development, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Aluminum hydroxide(equivalent to Dried Gel, USP) 400 mg
Magnesium hydroxide 135 mg

Purpose

Antacid

Uses

relieves: • heartburn • sour stomach • acid indigestion
• upset stomach due to these symptoms • overindulgence in food and drink

Warnings

Ask a doctor before use if you have
• kidney disease • a magnesium restricted diet

• a calcium restricted diet

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug. Antacids may interact with certain
prescription drugs

Stop use and ask a doctor if

symptoms last for more than 2 weeks

If pregnant or breast-feeding,

ask a health professional before use.

Keep this and all drugs out of the reach of children

In case of accidental overdose, seek professional assistance
or contact a Poison Control Center immediately.

Directions

• shake well before use
• do not exceed 18 teaspoons in a 24 hour period or use the
maximum dosage for more than 2 weeks
• adults and children 12 years of age and older: take 2 to 4
teaspoons (10-20 mL) between meals and at
bedtime or as directed by a doctor
• children under 12 years of age: ask a doctor

Other information

• do not freeze
• store at room temperature tightly closed
• each teaspoon contains: sodium 3 mg,
calcium 160 mg, magnesium 56 mg

Inactive ingredients

benzyl alcohol,
flavors, hydroxyethyl cellulose, purified water,
saccharin sodium, simethicone, sodium
carbonate, sorbitol, xanthan gum

Principal Display Panel

image of back label
ANTACID SUPREME CHERRY 
mylanta supreme cherry suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0115
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE400 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE135 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49580-0115-2355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/24/200910/06/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33103/24/200910/06/2016
Labeler - P & L Development, LLC (101896231)

Revised: 10/2016
 
P & L Development, LLC